From 2005 to 2009, the World Anti - Doping Agency banned
finasteride because it was discovered that the drug could be used
to mask steroid abuse. It was removed from the list effective
January 1, 2009, after improvements in testing methods made the ban
unnecessary. Athletes who used finasteride and were banned from
international competition include skeleton racer Zach Lund,
bobsledder Sebastien Gattuso, footballer Romário and ice hockey
goaltender José Théodore.

Brand names

Drug trade names include Propecia, marketed for male pattern
baldness ( MPB ), and Proscar, for benign prostatic hyperplasia (
BPH ); both are products of Merck & Co. There is 1 mg of
finasteride in Propecia and 5 mg in Proscar. Merck's patent on
finasteride for the treatment of BPH expired on June 19, 2006.
Merck was awarded a separate patent for the use of finasteride to
treat MPB. This patent expired in November 2013.

Controversy

Men in the US and Canada concerned about persistent sexual side
effects "coined the phrase 'post finasteride syndrome', which they
say is characterized by sexual, neurological, hormonal and
psychological side effects that can persist in men who have taken
finasteride for hair loss or an enlarged prostate". In 2012, a
health advocacy group called the Post - Finasteride Syndrome
Foundation was formed with the primary goal of finding a cure for
the reported syndrome and a secondary goal of raising awareness.
According to the company's 1Q2016 financial filing, Merck is a
defendant in 1,385 product liability lawsuits which have been filed
by customers alleging they have experienced persistent sexual side
effects following cessation of treatment with finasteride.

Usage

Sexual dysfunction

Whether finasteride causes long - term sexual dysfunction in some
men after stopping drug treatment is unclear. There are case
reports of persistent diminished libido or erectile dysfunction
after stopping the drug and the FDA has updated the label to inform
people of these reports. A 2010 review found moderate quality
evidence that finasteride increased the risk of sexual dysfunction,
but not that people stopped using it because of sexual side
effects.

When finasteride was originally approved for hair loss in 1997, the
FDA approval review reported that it appears well tolerated, with
the most common side effects being related to sexual function. In
many people these side effects resolve if the medication is stopped
and occasionally resolve even if the medication is continued. They
additionally state " the sexual functioning questionnaire seems to
have given a sensitive reflection of the disturbance on sexual
functioning ".

A meta - analysis and systematic review found that sexual
dysfunction, including erectile dysfunction, loss of libido, and
reduced ejaculate, may occur in 3.4 to 15.8% of men treated with
finasteride or dutasteride. This is linked to lower quality of life
and can cause stress in relationships. There is also an association
with lowered sexual desire. It has been reported that in a subset
of men, these adverse sexual side effects may persist even after
discontinuation of finasteride or dutasteride.

Specification

Test Items

Specification

Test Results

Description

White or off-white crystalline powder

Off-white crystalline powder

Specific rotation

-56°~-60°

-58.2°

Identification

IR

Matches with working standard

Complies

HPLC

Solubility

Freely soluble in chloroform and in alcohol;Very slightly soluble in water